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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

This study recruited participants between the years 2009-2013. The study was completed at the John D. Dingell VA Medical Center.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Participants did not meet the inclusion criteria. This was typically due to EKG abnormalities or high blood pressure.

Participants completed a "practice run" following consent to introduce them to equipment and procedures. Some participants choose not to continue following the practice run usually because of discomfort.

Reporting Groups

Description

OSA/Healthy - Males/Females - Wake/Sleep

We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.

Arm 2

We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.

Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Overall 40 participants were enrolled in Aim 1. One OSA male and two healthy male participants were enrolled but withdrew from the study. Thus, the total number that completed Aim 1 was 37 participants.

Reporting Groups

Description

Aim 1 - OSA Male - Sleep/Wake - Hypoxia/Sham

We plan to study 10 OSA males. These males will be matched with 10 females with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.

Aim 1 - OSA Female- Sleep/Wake - Hypoxia/Sham

We plan to study 10 OSA females. These females will be matched with 10 males with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.

Aim 1 - Healthy Males- Sleep/Wake - Hypoxia/Sham

We plan to study 10 healthy males. These males will be matched with 10 OSA males and 10 OSA females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.

Aim 1 - Healthy Females- Sleep/Wake - Hypoxia/Sham

We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.

Aim 2 - OSA - Hypoxia - Antioxidant/Placebo

We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.

Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia.

Aim 2 - Healthy - Hypoxia - Antioxidant/Placebo

We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

The primary limitation of this trial was the number of participants that required screening to recruit the participants that met the inclusion criteria for the study. However, once the participants were recruited few withdrew.